Overview

This book focuses on cell culture-produced viral vaccines to meet the needs of the rapidly expanding research and development in academia and industry in the field. This book introduces the basic principles of vaccination and the manufacturing of viral vaccines. Bioprocessing of Viral Vaccines, will provide an overview of the advanced strategies needed to respond to the challenges of new and established viral infection diseases. The first few chapters cover the basics of virology and immunology as essential concepts to understand the function and design of viral vaccines. The core of the content is dedicated to process development, including upstream processing and cell culture of viral vaccines, downstream processing, and extensive analytical technologies specific to viral vaccines. Advanced process analytical technologies (PAT) and Quality by Design (QbD) concepts are also introduced in the context of vaccine manufacturing. The case studies included cover inactivated, attenuated vaccines exemplified by influenza vaccines, sub-unit vaccines exemplified by Virus Like Particles (VLPs: HPV vaccines) and sub-unit vaccines (Flublock), vectored vaccines: adenoviruses and Vesicular stomatitis Virus (VSV) vectored vaccines, genomic vaccines (DNA and mRNA) vaccines as developed for COVID-19 response in particular and a review of COVID-19 vaccines approved or in advanced clinical trials. This book is aimed at graduate engineers and professionals in the fields of vaccinology, bioprocessing, and biomanufacturing of viral vaccines.

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9781032135519

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Amine Kamen is a professor of bioengineering at McGill University, and Canada Research Chair in bioprocessing of viral vaccines. He is a researcher emeritus of the National Research Council of Canada (NRC) where he was employed until early 2014, as head of the Process Development section of the Human Health Therapeutics Portfolio. At NRC, he established one of North America’s largest and most advanced governmental centers for animal cell culture addressing process development and scale-up of biologics. Also, he developed with his team and licensed to industry multiple technology platforms for efficient manufacturing of recombinant proteins and viral vectors and vaccines and led technology transfer to manufacturing sites for clinical evaluation and commercialization. His current research activities focus on uncovering mechanisms associated with cell production of viral vectors and viral vaccines, cell and metabolic engineering, process control and monitoring, and process analytical technologies of high-yield productions of viral vectors for gene delivery and vaccination. He has published over 170 papers in refereed international journals and acts as a consultant for several national and international private and public organizations. Laura Cervera is a Chemical Engineer from Universitat Autònoma de Barcelona (Barcelona, Spain). After graduating she did her PhD in Biotechnology on the topic “Strategies for improving production levels of HIV-1 VLPs by transient transfection of HEK 293 suspension cultures”. Then she moved to McGillUniversity (Montreal, Canada) to pursue her research on VLP production, this time using Insect cells as a platform. She came back to Barcelona to join a project on AAV production for gene therapy applications using HEK 293 cells.

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